Study of Telotristat Etiprate (LX1606) in Participants With Symptomatic Carcinoid Syndrome Not Managed by Stable-Dose Octreotide Therapy

Completed · Phase 2 · Has a placebo group

Conditions studied: Carcinoid Syndrome

In brief

The purpose of this study is to evaluate the safety and tolerability of telotristat etiprate (LX1606) versus a placebo control in participants with symptomatic carcinoid syndrome not managed by stable-dose long-acting octreotide therapy. Following determination of the maximally tolerated or effective dose, cohort expansion will occur to confirm effect on symptoms and safety profile.

Key facts

Study ID

NCT00853047

Run by

Lexicon Pharmaceuticals

People needed

23

Starts

2009-03-01

Expected to finish

2014-06-01

Last updated by the study team

2018-12-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males and females, aged 18 and older
• Biopsy-proven metastatic carcinoid tumor of the gastrointestinal (GI) tract with disease extent confirmed by computed tomography (CT), magnetic resonance imaging (MRI), or radionuclide imaging
• Symptoms not managed by stable-dose long-acting octreotide therapy (≥4 bowel movements per day)
• Ability to provide written informed consent

You may not qualify if…

• ≥12 high volume, watery bowel movements per day associated with a clinical syndrome of volume contraction, dehydration, or hypotension compatible with a "pancreatic cholera"-type clinical syndrome
• Sponsor-unacceptable clinical laboratory values for hematology and liver function tests at screening
• Karnofsky status ≤70% - unable to care for self
• Surgery within 60 days prior to screening
• A history of short bowel syndrome
• Life expectancy <12 months
• History of substance or alcohol abuse within 2 years prior to screening
• Previous exposure to a tryptophan hydroxylase (TPH) inhibitor
• Administration of any investigational drug within 30 days of screening or any therapeutic protein or antibody within 90 days of screening

Where it is running

• Hematology Oncology Services of Arkansas — Little Rock, Arkansas, United States
• UCSF Helen Diller Family Comprehensive Cancer Center — San Francisco, California, United States
• St. Francis Medical Group Oncology and Hematology Specialists — Indianapolis, Indiana, United States
• University of Iowa — Iowa City, Iowa, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• Nebraska Methodist Hospital — Omaha, Nebraska, United States
• UT M.D. Anderson Cancer Center — Houston, Texas, United States
• Texas Oncology - McAllen — McAllen, Texas, United States
• Texas Oncology - Weslaco — Weslaco, Texas, United States

Full record on ClinicalTrials.gov

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